da461cb0-430d-458a-98c0-f713e8d51ddd

SPL v5

SPL

SPL Set ID da461cb0-430d-458a-98c0-f713e8d51ddd

Route

dental

Published

Effective Date 2023-01-03

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

fluoride ion (2.72 g)

Identifiers & Packaging

Marketing Status

unapproved drug other active Since 2010-08-01

Dosage and Administration

1. Break protective tab adjacent to trigger. 2. Shake can thoroughly for at least 15 seconds before each use. 3. Hold can completely upside down to dispense and fill fluoride tray by slowly depressing the nozzle. (The foam will expand slightly higher than the fluoride tray.) 4. Dry tooth surfaces prior to inserting tray(s) in mouth. 5. Insert tray(s) into patient’s mouth and have them bite down for 1-4 minutes. 6. Remove tray(s) and have patient expectorate. 7. Advise the patient not to eat, drink or rinse for 30 minutes after the treatment.

Description

Product Name- ZOOBY, 1.23 % APF Foam (Happy Hippo Cake Flavor) Distributed By - Denticator Earth City, MO 63045. Net Weight - 4.4 OZ (125g) RX Only ZOOBY, 1.23 % APF Foam (Happy Hippo Cake Flavor) contains 1.23 % Fluoride Ion from 2.72 % Sodium Fluoride.Does not contain chlorofluorocarbon propellant. Gluten free.

Medication Information

Warnings

Do not spray toward open flame. Contents under pressure. Do not puncture or incinerate. Keep out of reach of children. Store between 59-86º F (15-30º C). Keep from freezing.

Refer to Material Safety Data Sheet for additional information. For emergencies contact INFOTRAC at 1-800-535-5053

Dosage and Administration

1. Break protective tab adjacent to trigger.

2. Shake can thoroughly for at least 15 seconds before each use.

3. Hold can completely upside down to dispense and fill fluoride tray by slowly depressing the nozzle. (The foam will expand slightly higher than the fluoride tray.)

4. Dry tooth surfaces prior to inserting tray(s) in mouth.

5. Insert tray(s) into patient’s mouth and have them bite down for 1-4 minutes.

6. Remove tray(s) and have patient expectorate.

7. Advise the patient not to eat, drink or rinse for 30 minutes after the treatment.

Description

Product Name- ZOOBY, 1.23 % APF Foam (Happy Hippo Cake Flavor)

Distributed By - Denticator Earth City, MO 63045.

Net Weight - 4.4 OZ (125g)

RX Only

ZOOBY, 1.23 % APF Foam (Happy Hippo Cake Flavor) contains 1.23 % Fluoride Ion from 2.72 % Sodium Fluoride.Does not contain chlorofluorocarbon propellant. Gluten free.

Indications

For the topical application of fluoride to aid in the protection against dental caries. Optimized low pH for a 1 minute fluoride treatments.

Product Label

Structured Label Content

Warnings

Do not spray toward open flame. Contents under pressure. Do not puncture or incinerate. Keep out of reach of children. Store between 59-86º F (15-30º C). Keep from freezing.

Refer to Material Safety Data Sheet for additional information. For emergencies contact INFOTRAC at 1-800-535-5053

Dosage and Administration

1. Break protective tab adjacent to trigger.

2. Shake can thoroughly for at least 15 seconds before each use.

3. Hold can completely upside down to dispense and fill fluoride tray by slowly depressing the nozzle. (The foam will expand slightly higher than the fluoride tray.)

4. Dry tooth surfaces prior to inserting tray(s) in mouth.

5. Insert tray(s) into patient’s mouth and have them bite down for 1-4 minutes.

6. Remove tray(s) and have patient expectorate.

7. Advise the patient not to eat, drink or rinse for 30 minutes after the treatment.

Description

Product Name- ZOOBY, 1.23 % APF Foam (Happy Hippo Cake Flavor)

Distributed By - Denticator Earth City, MO 63045.

Net Weight - 4.4 OZ (125g)

RX Only

ZOOBY, 1.23 % APF Foam (Happy Hippo Cake Flavor) contains 1.23 % Fluoride Ion from 2.72 % Sodium Fluoride.Does not contain chlorofluorocarbon propellant. Gluten free.

Indications

For the topical application of fluoride to aid in the protection against dental caries. Optimized low pH for a 1 minute fluoride treatments.

Product Label (Product label)

Advanced Ingredient Data

[{"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "2.72", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Warnings": "Do not spray toward open flame. Contents under pressure. Do not puncture or incinerate. Keep out of reach of children. Store between 59-86º F (15-30º C). Keep from freezing. Refer to Material Safety Data Sheet for additional information. For emergencies contact INFOTRAC at 1-800-535-5053", "Description": "Product Name- ZOOBY, 1.23 % APF Foam (Happy Hippo Cake Flavor) Distributed By - Denticator Earth City, MO 63045. Net Weight - 4.4 OZ (125g) RX Only ZOOBY, 1.23 % APF Foam (Happy Hippo Cake Flavor) contains 1.23 % Fluoride Ion from 2.72 % Sodium Fluoride.Does not contain chlorofluorocarbon propellant. Gluten free.", "Indications": "For the topical application of fluoride to aid in the protection against dental caries. Optimized low pH for a 1 minute fluoride treatments.", "Dosage and Administration": "1. Break protective tab adjacent to trigger. 2. Shake can thoroughly for at least 15 seconds before each use. 3. Hold can completely upside down to dispense and fill fluoride tray by slowly depressing the nozzle. (The foam will expand slightly higher than the fluoride tray.) 4. Dry tooth surfaces prior to inserting tray(s) in mouth. 5. Insert tray(s) into patient’s mouth and have them bite down for 1-4 minutes. 6. Remove tray(s) and have patient expectorate. 7. Advise the patient not to eat, drink or rinse for 30 minutes after the treatment."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:37:38.568351 · Updated: 2026-03-14T21:51:02.524501